Atlas

FDA-Inspected Site

Chemrite Copac LLC

9 FDA inspections are on record for Chemrite Copac LLC in Lannon, United States.

483· Form 483 issued

Lannon, United States · Last updated August 15, 2026

Overview

  • 9 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-04-11.

At a glance

Inspections

9

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Apr 2023 – 11 Apr 2023Human Drugs483On file
9 Jun 2016 – 15 Jul 2016Human DrugsWLView 483 →
9 Mar 2016 – 24 Mar 2016Human Drugs483View 483 →
7 Feb 2013 – 21 Feb 2013Medical Devices & Rad Health483View 483 →
21 Nov 2011Not recorded483View 483 →
19 Mar 2009Not recordedClean
23 Aug 2006Not recordedClean
12 Mar 2004Not recordedClean
6 Oct 1999Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

15 Jul 2016
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jesse P Romenesko, Shalonda C Clifford, Joel D Hustedt, Jessica L Barr

15 Jul 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jesse P Romenesko, Shalonda C Clifford, Joel D Hustedt, Jessica L Barr

15 Jul 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jesse P Romenesko, Shalonda C Clifford, Joel D Hustedt, Jessica L Barr

15 Jul 2016
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Jesse P Romenesko, Shalonda C Clifford, Joel D Hustedt, Jessica L Barr

15 Jul 2016
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Jesse P Romenesko, Shalonda C Clifford, Joel D Hustedt, Jessica L Barr

Investigators

FDA investigators tied to this site in the record.

Jesse P Romenesko2 insp.
Shalonda C Clifford2 insp.
Sandra A Hughes2 insp.
Michele L Glendenning1 insp.
Soyinka S Eneng1 insp.
Joel D Hustedt1 insp.
Jessica L Barr1 insp.
Nicole C Shokatz1 insp.
Kathryn M Mogen1 insp.
Gregory W Smith1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.67(b)Cited across public-safe Form 483 observations4x
21 CFR 211.113(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations3x
21 CFR 211.165(e)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(d)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(c)Cited across public-safe Form 483 observations2x
21 CFR 211.42(a)Cited across public-safe Form 483 observations2x
21 CFR 211.48(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(c)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(b)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Chemrite Copac LLC's 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat